# Sulzer Calcitek, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 9 (1997–2001): 9 510(k) clearances
- Product codes: DZE (8), EBF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K010073: Spline Dental Implant System (Jan 19, 2001)
- K001786: Temporary Gingival Cuff and Impression Post and Implant Analog (Jun 21, 2000)
- K984536: Removable Cuff Abutment (Jun 16, 1999)
- K982305: Spline Dental Implant System-Temporary Abutment (Sep 22, 1998)
- K981562: Spline Dental Implant System - Spline XI Implant (Jul 30, 1998)
- K973521: Variable Parallel Pin (Nov 20, 1997)
- K970752: Spline Engaging Shouldered Abutment System (Jun 23, 1997)
- K970127: Edosseous Dental Implant (Jun 23, 1997)

Source page: https://510kreport.com/company/sulzer-calcitek